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Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

NCT00578175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1851

Last updated 2018-10-09

Study results available
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Summary

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Conditions

Interventions

BIOLOGICAL

Priorix-Tetra™ (MMRV vaccine 208136)

One subcutaneous injection.

BIOLOGICAL

ProQuad®

One subcutaneous injection.

BIOLOGICAL

Havrix®

Two intramuscular injections.

BIOLOGICAL

Prevnar®

One intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-20
Primary Completion
2009-02-24
Completion
2009-03-17

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578175 on ClinicalTrials.gov